Sprecher

Dr Rainer Gnibl, GMP-Inspectorate, Germany

Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Aidan Madden, FivePharma, Ireland

Dr Martin Melzer, Chemgineering, Germany

Zielsetzung

During this course, you will learn all relevant aspects to implement and/ or improve your Change Control System fulfilling the regulatory GMP requirements. You will get to know the whole process from initiation over implementation to regulatory submissions. You will also have the possibility to work on practical examples.

Change control systems should be an integral part of the quality management system of each company. Their task and aim is to ensure that all announced or requested changes are carefully checked and completely documented and authorised.

Hintergrund

Before starting implementing the change, many question need to be answered like:

How is the change classified

Is it a variation or a change

Who needs to be informed

What are the regulatory consequences

A sound change control system is used to manage changes of all types. The Change Control process is necessary to prevent inappropriate changes from occurring. All GMP-relevant changes should only be made with a complete review and approval of the QA and any other department that might be impacted by the change.

Only if all functions involved in the process are working together and know what needs to be considered, the change control process will run smoothly and fast enough to benefit from the change.

It is of high importance to know all relevant aspects of the whole change control process and the consequences a change might have.

Zielgruppe

This course is designed for all personnel involved in the Change Control process at their company and for decision makers who want to improve the existing systems.

It is addressed to persons from Manufacturing, Quality Control and Quality Assurance but also from from Regulatory Affairs.

Programm

Change Control - Inspectors Expectations for GMP Compliance

Essentials for SOP on Change Control

Internal & external Changes

PQS Interfaces

EU requirements

Change in Quality-Culture?

How to handle Changes in US

21 CFR 314.70

Changes to an approved NDA and ANDA

Examples (PAS, CBE, AR)

Annual Report

Comparability Protocol (US) vs. Change Management Protocol (EU)

Change Control Management; General Points to Consider: How to manage it, who’s involved and when does it apply

Identification and classification of changes

Risk and impact analysis of changes

Change control as management tool

Management of changes with suppliers and contractors

Interactive Session: How to implement a comprehensible Change Control System in your Company

EU Variation Procedure

Change Control Handbook

SOPs

Change Control Protocol

Forms

with practical advice how to implement and use them

List of examples:
As a delegate you will get a comprehensive list of examples for Variations.

What’s a Change and how to proceed

Technical changes: Change Control or not

How to deal with software updates

Risk Analysis in Change Control

Classification of Changes

How to document changes

Change Control in the context of Product Lifecycle Management

Product Development Strategies and Change Control

Post Approval Change Management/ Comparability Protocols

ICH Q 12 Product Lifecycle Management

Workshops: Interactive exercises to examine and evaluate some real examples of various changes: